UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058079 |
|---|---|
| Receipt number | R000066241 |
| Scientific Title | Effects of aerobic-based and resistance-based exercise snacks on physical function and cardiometabolic outcomes in community-dwelling older adults: an exloratory randomized controlled trial |
| Date of disclosure of the study information | 2025/06/04 |
| Last modified on | 2026/09/15 17:34:26 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Effects of aerobic-based and resistance-based exercise snacks on health outcomes in community-dwelling older adults
Acronym
Effects of exercise snacks on health outcomes in older adults
Scientific Title
Effects of aerobic-based and resistance-based exercise snacks on physical function and cardiometabolic outcomes in community-dwelling older adults: an exloratory randomized controlled trial
Scientific Title:Acronym
Effects of exercise snacks on health outcomes in older adults: an exploratory randomized controlled trial
Region
| Japan |
Condition
Condition
Healthy community-dwelling older adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To Examine the effects of aerobic-based and resistance-based exercise snacks on muscle strength, aerobic endurance, functional mobility, body composition, and cardiometabolic outcmes in community-dwelling older adults
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Maximal voluntary isometric knee extension strength, Aerobic endurance, Functional mobility.
Key secondary outcomes
Blood profiles, Body composition, Insulin resistance
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Numbered container method
Intervention
No. of arms
3
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
3 times repetitions of 60 sec high-intensity resistance exercise (squats using body weight) with 60 sec rest, twice a day, three days a week for eight weeks
Interventions/Control_2
3 times repetitions of 60 sec high-intensity resistance exercise (step exercise) with 60 sec rest, twice a day, three days a week for eight weeks
Interventions/Control_3
controlled
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 60 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) Older adults aged 60 or over, (2) with no health problems, (3) who are not frail, (4) who are physically inactive
Key exclusion criteria
(1) Current smoking, (2) Classification as physically frail during the initial screening, (3) Engagement in at least 150 min per week of moderate to vigorous physical activity at the initial screening, (4) A history of cardiovascular disease or other relevant medical conditions within the previous 6 months
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Takuma |
| Middle name | |
| Last name | Yanaoka |
Organization
Hiroshima University
Division name
Graduate School of Humanities and Social Sciences
Zip code
7398524
Address
Kagamiyama 1-1-1, Higashi-Hiroshima, Hiroshima, Japan
TEL
0824246846
yanaoka@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Takuma |
| Middle name | |
| Last name | Yanaoka |
Organization
Hiroshima University
Division name
Graduate School of Humanities and Social Sciences
Zip code
7398524
Address
Kagamiyama 1-1-1, Higashi-Hiroshima, Hiroshima, Japan
TEL
0824246846
Homepage URL
https://yanaokalab.hiroshima-u.ac.jp/
yanaoka@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima University
Institute
Department
Personal name
Funding Source
Organization
Meiji Yasuda Life Foundation of Health and Welfare
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Review Board, Graduate School of Humanities and Social Sciences, Hiroshima University
Address
1-1-1 Kagamiyama, Higashi-hiroshima
Tel
0824246705
ed-ken-zai@office.hiroshima-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
広島大学
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 06 | Month | 04 | Day |
Related information
URL releasing protocol
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066241
Publication of results
Unpublished
Result
URL related to results and publications
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066241
Number of participants that the trial has enrolled
31
Results
8 weeks aerobic-based (AES) and resitance-based exercise snacks (RES) improved, isometric knee extension strength, aerobic endurance, and functional pgysical capacity in community-dwelling older adults.
Results date posted
| 2026 | Year | 08 | Month | 28 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Healthy community-dwelling older adults (age: >60 year old).
Participant flow
Participants were recruited through the distribution of flyers between July and November 2025, and 40 individuals were initially recruited for the study.
Following the eligibility assessment, 31 apparently healthy community-dwelling older adults aged 63 to 84 years were enrolled in the study. Participants were randomly allocated a control group (CON), an aerobic-based exercise snacks group (AES), or a resistance-based exercise snacks group (RES), using sequentially numbered, opaque, sealed envelopes. The allocation procedure was conducted by an independent third party who was not involved in the study. Outcome assessors were blinded to group allocation. Participants were not informed of the study hypotheses or the intervention protocols assigned to the other groups. One participant in CON was unable to complete the Post assessment because of an injury sustained during the study period (week 5). In AES, one participant discontinued the intervention because of illness at week 6, and two participants discontinued participation after week 2 because of time constraints. Consequently, 9 participants in CON, 7 in AES, and 11 in RES completed the intervention period and Post assessments.
The study consisted of an 8-week intervention, with assessments conducted before the intervention (Baseline), after 4 weeks (Middle), and after 8 weeks (Post). All assessments were conducted at the same time of day (9:00 to 11:00). Participants were instructed to maintain their usual lifestyle and dietary habits throughout the study period.
Adverse events
One participant in the control group sustained an injury following a fall during a study assessment at week 5. The event was not related to the exercise interventions. No adverse events related to the exercise interventions were reported.
Outcome measures
Body composition, Maximal voluntary isometric knee extension strength, Aerobic endurance measured by 6-min walk test, Functional physical capacity measured by timed-up and go test, Gait speed, Center of pressure velocity measured by single leg standing with eyes open, Resting blood pressure, Blood profiles, Insulin resisntace.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2025 | Year | 04 | Month | 02 | Day |
Date of IRB
| 2025 | Year | 04 | Month | 02 | Day |
Anticipated trial start date
| 2025 | Year | 05 | Month | 27 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2026 | Year | 09 | Month | 04 | Day |
Date trial data considered complete
Date analysis concluded
| 2026 | Year | 09 | Month | 04 | Day |
Other
Other related information
Management information
Registered date
| 2025 | Year | 06 | Month | 04 | Day |
Last modified on
| 2026 | Year | 09 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066241
